Form 8-K

8-K — Tonix Pharmaceuticals Holding Corp.

Accession: 0001999371-26-009289

Filed: 2026-04-29

Period: 2026-04-29

CIK: 0001430306

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Regulation FD Disclosure

Item: Other Events

Item: Financial Statements and Exhibits

Documents

8-K — tnxp_8k-0422926.htm (Primary)

EX-99.01 — PRESS RELEASE (ex99-01.htm)

EX-99.02 — TNX-4800: A MONOCLONAL ANTIBODY (MAB) TO PROTECT AGAINST LYME DISEASE (ex99-02.htm)

GRAPHIC (ex99-02_01.jpg)

GRAPHIC (tonixlogo.jpg)

XML — IDEA: XBRL DOCUMENT (R1.htm)

8-K — CURRENT REPORT

8-K (Primary)

Filename: tnxp_8k-0422926.htm · Sequence: 1

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0001430306

2026-04-29

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UNITED

STATES

SECURITIES

AND EXCHANGE COMMISSION

Washington,

D.C. 20549

FORM 8-K

CURRENT

REPORT

Pursuant

to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date

of report (date of earliest event reported): April

29, 2026

TONIX PHARMACEUTICALS HOLDING CORP.

(Exact

name of registrant as specified in its charter)

Nevada

001-36019

26-1434750

(State

or Other Jurisdiction

of Incorporation)

(Commission

File Number)

(IRS

Employer

Identification No.)

200

Connell Drive, Suite

3100, Berkeley

Heights, New

Jersey 07922

(Address

of principal executive offices) (Zip Code)

Registrant’s

telephone number, including area code: (862)

799-8599

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing

obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

☐ Written communications

pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting

material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement

communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement

communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common

Stock

TNXP

The

NASDAQ

Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the

Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this

chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended

transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the

Exchange Act. ☐

Item 7.01

Regulation FD Disclosure.

April 29, 2026, Tonix Pharmaceuticals Holding Corp. (the “Company”) announced program updates on its TNX-4800 (formerly known

as mAb 2217LS) product candidate for protection against Lyme disease, and presented a poster on TNX-4800 Phase 1 data at the 4th

Annual Ticks and Tickborne Diseases Symposium. A copy of the press release that discusses these matters is furnished hereto as Exhibit

99.01, and is incorporated herein by reference. A copy of the poster is furnished hereto as Exhibit 99.02, and is incorporated herein

by reference.

The

information in this Item 7.01 of this Current Report on Form 8-K, including Exhibits 99.01 and 99.02 attached hereto, shall not be deemed

“filed” for purposes of Section 18 of the United States Securities Exchange Act of 1934, as amended (the “Exchange Act”),

or otherwise subject to the liabilities of that section, nor shall they be deemed incorporated by reference in any filing under the United

States Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, except as shall be expressly set forth

by specific reference in such a filing.

Item 8.01

Other Events.

April 29, 2026, the Company announced program updates on its TNX-4800 product candidate for protection against Lyme disease, and presented

TNX-4800 Phase 1 data at the 4th Annual Ticks and Tickborne Diseases Symposium.

The Company plans to initiate an adaptive Phase 2 field study of

TNX-4800 in the first half of 2027, pending FDA agreement. The field study is intended to test a fixed subcutaneous (“SC”)

two-dose regimen of TNX-4800, with the first dose administered in the Spring and a second dose administered two months later. The primary

endpoint is protection against Lyme disease for six months following the initial dose. The Company believes that the Phase 1 pharmacokinetic

data support this study design. Each dose is expected to provide exposures comparable to the 5 mg/kg SC dose evaluated in the Phase 1

study. The Company has scheduled a Type C meeting with the U.S. Food and Drug Administration early in the third quarter of 2026 to discuss

the Phase 2 field study design.

Forward-Looking Statements

This Current Report on Form 8-K

contains certain forward-looking statements within the meaning of Section 27A of the Securities Act, Section 21E of the Exchange Act and

the Private Securities Litigation Reform Act, as amended, including those relating to the Company’s product development, clinical

trials, clinical and regulatory timelines and approvals and other statements that are predictive in nature. These forward-looking statements

are based on current expectations, estimates, forecasts and projections about the industry and markets in which the Company operates and

management’s current beliefs and assumptions.

These statements may be identified

by the use of forward-looking expressions, including, but not limited to, “expect,” “anticipate,” “intend,”

“plan,” “believe,” “estimate,” “potential,” “predict,” “project,”

“should,” “would” and similar expressions and the negatives of those terms. These statements relate to future

events and involve known and unknown risks, uncertainties, and other factors which may cause actual results, performance or achievements

to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements.

Such factors include those set forth in the Company’s filings with the Securities and Exchange Commission. Prospective investors

are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this Current Report on

Form 8-K. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information,

future events or otherwise.

Item 9.01

Financial Statements and Exhibits.

(d)

Exhibit No.

Description.

99.01

Press Release of the Company, dated April 29, 2026

99.02

TNX-4800: A Monoclonal Antibody (mAb) to Protect Against Lyme Disease

104

Cover Page Interactive Data

File (embedded within the Inline XBRL document)

SIGNATURE

Pursuant to the requirement of the Securities Exchange Act of 1934, the registrant has duly caused this

report to be signed on its behalf by the undersigned thereunto duly authorized.

TONIX PHARMACEUTICALS HOLDING CORP.

Date:

April 29, 2026

By:

/s/

Bradley Saenger

Bradley

Saenger

Chief

Financial Officer

EX-99.01 — PRESS RELEASE

EX-99.01

Filename: ex99-01.htm · Sequence: 2

TONIX PHARMACEUTICALS HOLDING CORP. 8-K

EXHIBIT 99.01

Tonix Pharmaceuticals Announces Presentation of

Phase 1 Data and Plans for an Adaptive Phase 2 Field Study of TNX-4800 (anti-Borrelia OspA monoclonal antibody) for the Prevention

of Lyme Disease at the 4th Annual Ticks and Tickborne Diseases Symposium at Johns Hopkins University

Company on track to initiate a randomized, double-blind,

placebo-controlled, adaptive Phase 2 field study in the first half of 2027, pending FDA agreement

Phase 2 field study expected to test a two-dose

regimen of TNX-4800 subcutaneous with an initial Spring dose followed by a Summer booster two months later; the primary endpoint is Lyme

disease prevention for six months

TNX-4800 is expected to provide protection against

Lyme disease within two days of the first dose for the peak of the U.S. Lyme season

BERKELEY HEIGHTS, N.J., April 29, 2026 (GLOBE NEWSWIRE) -- Tonix Pharmaceuticals Holding

Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully integrated, commercial biotechnology company, announced

presentation of Phase 1 data and plans for an adaptive Phase 2 field study of TNX-4800 (formerly known as mAb 2217LS)1,2 for

the prevention of Lyme disease in the U.S., at the 4th Annual Ticks and Tickborne Diseases Symposium. The Phase 2 study is

expected to initiate in the first half of 2027, pending FDA agreement.

The Phase 1 study was conducted by a team at UMass Chan Medical School

led by Mark S. Klempner, MD, Professor of Medicine at UMass Chan and an inventor of TNX-4800. The adaptive Phase 2 field study is being

planned by Tonix, which licensed TNX-4800 from UMass Chan Medical School in 2025.

TNX-4800 is a long-acting bactericidal (or borreliacidal), human monoclonal

antibody (mAb) that targets the outer surface protein A (OspA) of Borrelia burgdorferi, the spirochete bacteria that causes

99.9% of Lyme disease cases in the U.S.3,4 TNX-4800 was engineered to include a crystallizable fragment (Fc) domain that provides

an extended half-life. Tonix is developing TNX-4800 for the prevention of Lyme disease during the U.S. tick season. There are currently

no marketed U.S. Food and Drug Administration (FDA)-approved vaccines or prophylactics to protect against Lyme disease.

“We plan to initiate an adaptive Phase 2 field study in the first half of 2027

pending FDA agreement,” said Seth Lederman, MD, Chief Executive Officer of Tonix Pharmaceuticals. “We intend to test a two-dose

regimen of TNX-4800, with the first dose administered in the Spring and a second dose administered two months later, for protection against

Lyme disease for six months following the initial dose as the primary endpoint. We believe the Phase 1 pharmacokinetic (PK) data support

this study design. Each fixed subcutaneous (SC) dose is expected to provide exposures comparable to the 5 mg/kg SC dose evaluated in Phase

1. We have a scheduled meeting with the FDA early in the third quarter of 2026. We look forward to advancing the clinical investigation

of TNX-4800 as we strive to overcome the major public health challenges posed by Lyme disease.”

Dr. Lederman continued, “As a long-acting monoclonal antibody that

offers passive immunity against the Lyme-causing bacteria within two days, we believe TNX-4800 offers significant advantages over the

alum-based combination multi-OspA subunit vaccine in late-stage clinical development. Lyme disease vaccines that elicit antibodies to

OspA take more than six months to offer protection and require complex immunization schedules which are obstacles to adherence. A previously

approved alum-based OspA subunit vaccine was withdrawn due to poor uptake,6 potentially relating to its complex immunization

schedule. We believe TNX-4800’s differentiating characteristics could offer meaningful improvements for people seeking protection

from Lyme disease.”

A copy of the poster is available under the Scientific Presentations tab

on the Tonix website at www.tonixpharma.com.

Adaptive Phase 2 Field Study Plans

Pending FDA agreement, the Company plans to initiate an adaptive field study in the

first half of 2027. The Company plans to study TNX-4800 in a randomized, double-blind, placebo-controlled, adaptive Phase 2 field study

to evaluate the efficacy of a two-dose regimen of TNX-4800 SC, in preventing the first occurrence of confirmed Lyme disease during the

primary efficacy surveillance period (Day 3 through Month 6 following administration). The two-dose regimen of TNX-4800 was selected for

the Phase 2 field study based on the pharmacokinetic results of the Phase 1 study. Each fixed dose is expected to provide exposures comparable

to the 5 mg/kg dose evaluated in Phase 1. The first dose will be administered in the Spring and the second booster dose will be administered

two months later. Participants will include adolescents and adults 16 years of age and older in Lyme-endemic areas in the U.S. The primary

endpoint will be the prevention of Lyme disease for six months (comparison of TNX-4800 group and placebo group) following the initial

dose. The Company has scheduled a Type C meeting with the FDA early in the third quarter of 2026 to discuss the planned adaptive Phase

2 field study design.

The Company expects to have Good Manufacturing Practice (GMP) investigational

product available for clinical testing in early 2027.

About TNX-4800

TNX-4800 (formerly known as mAb 2217LS) is a long-acting bactericidal,

human monoclonal antibody with an engineered extended half-life that targets the outer-surface protein A (OspA) on Lyme-causing Borrelia bacteria.

When TNX-4800-containing blood is ingested by the tick, TNX-4800 either kills or blocks the maturation of Borrelia burgdorferi in

the mid-gut of infected deer ticks. The Company in-licensed TNX-4800 from UMass Chan Medical School in 2025. Published work in animals

showed that TNX-4800 serum levels of at least 21 μg/ml, were approximately 95% effective at preventing infection of non-human primates

after six days of exposure to ticks infected with Borrelia burgdorferi.1,2 TNX-4800 was derived from mAb 2217 by

amino acid substitutions in its Fc domain, which serve to prolong the serum half-life. As a monoclonal antibody, TNX-4800 is designed

to provide passive immunity against Lyme disease within two days without relying on the recipient’s immune system to generate antibodies.

TNX-4800 also avoids the complex immunization schedules required for an alum-based combination multi-OspA subunit vaccine in development7 and

the FDA-approved alum-based OspA subunit vaccine that was withdrawn from the market.8 TNX-4800 is protected by Issued

US Patent US 10,457,721, which is licensed from

UMass Chan with expiry in January 2036, excluding any possible Patent Term

Extension based on the duration of the clinical trials and the FDA approval process.

TNX-4800 Phase 1 Study Results

TNX-4800 was studied in a randomized, double-blind, sequential dose-escalation study

(NCT04863287) that evaluated safety, tolerability, PK, and immunogenicity of TNX-4800 in healthy adults. 44 subjects were randomized,

and 41 completed the study. Subjects received a single SC dose of placebo or TNX-4800 at 0.5, 1.5, 5, or 10 mg/kg. Safety was assessed

via clinical and lab evaluations. Results showed no significant clinical or laboratory safety signals. All drug-related adverse events

were mild or moderate, except for a single severe adverse event that was deemed not drug-related. Drug exposure increased by approximately

25 times for a 20-times increase in dose. Serum TNX-4800 was measurable at the earliest sampling time of two days, indicating rapid systemic

absorption. At the highest dose of TNX-4800 tested in rats with 1.5-fold higher exposure compared to 10 mg/kg cohort, no adverse toxicity

was observed, thus the highest dose tested was considered No Observed Adverse Effect Level (NOAEL). Confirmed anti-drug antibodies (ADSs)

were observed transiently in <10% of treated participants, with no impact on PK. TNX-4800 was determined to be generally safe and well

tolerated.

About Lyme Disease

In the U.S., Lyme disease is caused by the spirochete bacteria Borrelia burgdorferi. Lyme disease remains the most common

vector-borne infection in the United States, and its incidence is climbing each year, due to the expanding the habitat range for ticks.8

Approximately 87 million people in the United States live, work, or vacation in a tick-endemic area placing them at risk of contracting

the disease.9 It occurs most commonly in the Northeast, mid-Atlantic, and upper-Midwest regions. Lyme disease bacteria are

transmitted through the bite of infected Ixodes ticks. Typical symptoms include fever, headache, fatigue, and

a characteristic skin rash called erythema migrans. If left untreated, infection can spread to joints, heart, and nervous system.

Laboratory testing is helpful if used correctly and performed with FDA-cleared tests. Although many cases of Lyme disease can be treated successfully

with antibiotics, diagnosis and treatment are often delayed or missed. Chronic Lyme is considered an Infection Associated Chronic Illness

(IACI), and is a chronic, debilitating disease state characterized by joint and muscle pain, fatigue, and other symptoms.10

Citations

1Schiller ZA, et al. J Clin Invest. 2021 131(11):e144843.

2Wang Y, et al. J Infect Dis. 2016. 214(2):205-11.

3Marques AR, et al. Emerg Infect Dis. 2021. 27(8):2017-2024.

4Pritt BS, et al. Lancet Infect Dis. 2016. 6(5):556-564.

5 Nigrovic LE, et al. Epidemiol Infect. 2006. Aug 8;135(1):1-8.

6Comstedt P, et al. Vaccine. 2015 33(44):5982-8.

7Connaught’s (ImuLyme™) and SmithKline Beecham’s

(LYMErix™) Lyme disease vaccines were withdrawn. Nigrovic LE, et al. Epidemiol Infect. 2007 135(1):1-8.

8Gomes-Solecki M, et. al. Clin Infect Dis. 2020

70(8):1768-1773.

9Kugeler KJ, et al. Emerg Infect Dis. 2021. 27(2):616-619.

10National Academies of Sciences, Engineering, and Medicine.

2025. Charting a Path Toward New Treatments for Lyme Infection-Associated Chronic Illnesses. Washington, DC: The National

Academies Press. https://doi.org/10.17226/28578.

Tonix Pharmaceuticals Holding Corp.

Tonix Pharmaceuticals* is a fully integrated, commercial-stage biotechnology

company focused on central nervous system (CNS) and immunology treatments in areas of high unmet medical need. TONMYA® (cyclobenzaprine

HCl sublingual tablets 2.8 mg) is the first new treatment for fibromyalgia in adults in more than 15 years. Tonix’s CNS commercial

infrastructure supports its marketed products, including its acute migraine products, Zembrace® Symtouch® (sumatriptan injection

3 mg) and Tosymra® (sumatriptan nasal spray 10 mg). Tonix is investigating TONMYA in Phase 2 clinical trials to evaluate its potential

in major depressive disorder and acute stress disorder/acute stress reaction. Tonix is also advancing a pipeline of immunology programs,

including TNX-4800, a Phase 2 ready long-acting human anti-Borrelia OspA monoclonal antibody (mAb) for the prevention of Lyme disease

in the U.S., and TNX-1500, a Phase 2 ready third-generation CD154/CD40 ligand (CD40L) inhibitor for the prevention of kidney transplant

rejection. In addition, Tonix is progressing TNX-2900 (intranasal potentiated oxytocin), which is Phase 2 ready for the treatment of Prader-Willi

syndrome, a rare disease. To learn more, visit www.tonixpharma.com.

*Tonix’s product development candidates are investigational new drugs

or biologics; their efficacy and safety have not been established and have not been approved for any indication.

Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines.

TONMYA is a registered trademark of Tonix Pharma Limited. All other marks are property of their respective owners.

Forward Looking Statements

Certain statements in this press release are forward-looking within the

meaning of the Private Securities Litigation Reform Act of 1995 including those relating to the completion of the offering, the satisfaction

of customary closing conditions, the intended use of proceeds from the offering and other statements that are predictive in nature. These

statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,”

“estimate,” “expect,” and “intend,” among others. There are a number of factors that could cause actual

events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks

related to the failure to successfully launch and commercialize TONMYA® and any of our approved products; risks related to the failure

to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the timing and progress of clinical development

of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government

or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition.

As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization

of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read

the risk factors set in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, as filed with the SEC on

March 12, 2026, and periodic reports filed with the SEC on or after the date thereof. Tonix does not undertake an obligation to update

or revise any forward-looking statement. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors

and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Investor Contacts

Jessica Morris

Tonix Pharmaceuticals

investor.relations@tonixpharma.com

(862) 799-8599

Brian Korb

astr partners

(917) 653-5122

brian.korb@astrpartners.com

Media Contacts

Deborah Elson

Tonix Pharmaceuticals

deborah.elson@tonixpharmaceuticals.com

Ray Jordan

Putnam Insights

ray@putnaminsights.com

EX-99.02 — TNX-4800: A MONOCLONAL ANTIBODY (MAB) TO PROTECT AGAINST LYME DISEASE

EX-99.02

Filename: ex99-02.htm · Sequence: 3

TONIX PHARMACEUTICALS HOLDING CORP. 8-K

EXHIBIT 99.02

Serum concentration, µg/mL Observed Phase 1 Pharmacodynamics Study participants randomized 1:1 to receive TNX - 4800 or placebo Dose 1 Tick Season Day 1 Day 60 6 months 2027 Planned TNX - 4800 Adaptive Phase 2 Field Study Design Dose 2 Surveillance Summary Conclusions Results References Design of Planned Phase 2 Study Multiple Approaches Informing Protective Exposure TNX - 4800 Long - Acting Anti - OspA Monoclonal Antibody Design Methodology Phase 1 Study Design Anti - OspA mAb TNX - 4800 Blocks Differentiation of Borrelia From the Preinfectious to Infectious Stage, Migration to Salivary Glands, and Transmission 6 OspA Is an Outer Membrane Protein on Borrelia That Facilitates Bacterial Adherence to the Tick Midgut 1 - 3 TNX - 4800: A Monoclonal Antibody ( mAb ) to Protect Against Lyme Disease M.S. Klempner, MD 1 ; Y. Wang, MD 1 ; J. Sullivan - Bolyai, MD 1 ; G. Sullivan, MD 2 ; G. Chen - Phillips, MD 3 ; Z. Rosenberg, MD 2 ; S. Lederman, MD 2 • Borrelia burgdorferi causes 99.9% of Lyme disease cases in the US • There are currently no marketed US Food and Drug Administration (FDA) - approved vaccines or prophylactics to protect against Lyme disease • TNX - 4800 is a long - acting borreliacidal, human monoclonal antibody ( mAb ) with an engineered crystallizable fragment (Fc) domain for an extended half - life that targets outer surface protein A ( OspA ) of Borrelia burgdorferi • TNX - 4800 was studied in a phase 1, randomized, double - blind, sequential dose - escalation study (NCT04863287) that evaluated safety, tolerability, pharmacokinetics (PK), and immunogenicity of TNX - 4800 in healthy adults • The phase 1 data support a planned adaptive phase 2 field study, pending FDA agreement, to evaluate the safety and efficacy of TNX - 4800 in preventing primary Lyme disease in volunteers from Lyme - endemic areas • TNX - 4800 is being developed as a prophylactic to be administered subcutaneously in the spring with a booster after 2 months, which is expected to provide protection within 2 days for at least 6 months to people in endemic areas during the US tick season Abstract Introduction • Drug exposure increased by approximately 25 times for a 20 - times increase in dose • Serum TNX - 4800 was measurable at the earliest sampling time of 2 days, indicating rapid systemic absorption • TNX - 4800 concentrations remained quantifiable for >200 days in 80% of volunteers at the lowest dose and for up to 350 days in the majority of volunteers at higher doses ( ie , ≥1.5 mg/kg) • Mean half - life ranged from 62 t o 69 days across groups. Serum concentrations remained quantifiable for up to 12 months in most volunteers. Mean exposure for the 10 mg/kg cohort was less than 17% of the highest exposures in a rat toxicology study • Transient low levels of antidrug antibodies were detected in <10% of treated volunteers, with no impact on PK • All drug - related adverse events (AEs) were mild or moderate: injection site AEs 14%, headache 12%, COVID - 19 and fatigue 9%, with rest reported in 2 of fewer cases (≤6%) • TNX - 4800 acts inside the tick to kill Borrelia and block the differentiation and transmission of Borrelia • Estimates of MEC indicate that serum levels of 21 μ g/mL in nonhuman primates are a ceiling but that lower serum levels can be protective • Phase 1 study of TNX - 4800, a long - acting, human mAb , showed no significant clinical or laboratory safety signals • Serum TNX - 4800 was measurable at the earliest sampling time of 48 hours, indicating rapid absorption • TNX - 4800 was found to be safe when administered to healthy volunteers • The PK of TNX - 4800 were typical of a human IgG1 with an Fc domain mutation that extends half - life 1 UMass Chan Medical School, Worcester, MA; 2 Tonix Pharmaceuticals, Inc., Berkeley Heights, NJ; 3 Consultant to Tonix Primary Objective : • Evaluate safety and tolerability of a SC injection of TNX - 4800 when administered to healthy volunteers Secondary Objective : • Evaluate PK of a SC dose of TNX - 4800 when administered to healthy volunteers Study Population : • Healthy male and female subjects, aged 19 to 65 years, inclusive. 44 volunteers enrolled; 41 completed 1. de Silva AM, et al. J Exp Med . 1996;183(1):271 - 275. 2. Radolf JD, et al. Nat Rev Microbiol . 2012;10(2):87 - 99. 3. Anderson C, et al. Pathogens. 2021;10(3):281. 4. Dattwyler RJ, et al. NPJ Vaccines . 2022;7(1):10. 5. de Silva AM, et al. Infect Immun . 1999;67(1):30 - 35. 6. Woodman ME, et al. FEMS Immunol Med Microbiol . 2008;54(2):277 - 282. 7. Schiller ZA, et al. J Clin Invest. 2021;131(11):e144843. 8. Wang Y, et al. J Infect Dis. 2016;214(2):205 - 211. 9. Regoes RR, et al. Antimicrob Agents Chemother . 2004;48(10):3670 - 3676. Transmission Adherence Midgut OspA Some Borrelia killed Blood Meal No TNX - 4800 mAb Blood Meal With TNX - 4800 mAb Migration Blood Meal mAb binds OspA , no downregulation No Transmission Mouthpiece Salivary glands No Migration No metamorphosis Some Borrelia killed Migration Blood Meal Iron - dependent OspA downregulation Mouthpiece Salivary glands OspC Migration OspC upregulation Tick - to - Human Transmission TX - 4800 dose (mg/kg) No. of participants Cohort 0.5 10 TNX - 4800 2 placebo 1 1.5 8 TNX - 4800 2 placebo 2 5 8 TNX - 4800 2 placebo 3 10 8 TNX - 4800 2 placebo 4 Participants received either placebo or TNX - 4800 by subcutaneous (SC) injection OspC OspA • TNX - 4800 (formerly 2217LS) is a long - acting borreliacidal, human mAb with an engineered Fc domain for an extended half - life that targets OspA of Borrelia burgdorferi 7,8 • TNX - 4800 is being developed as a prophylactic to be administered subcutaneously in the spring with a booster after 2 months, which is expected to provide protection within 2 days for at least 6 months to people in endemic areas during the US tick season • TNX - 4800 avoids the onerous immunization regimens of over 6 to 12 months for protection required by OspA vaccines in development • TNX - 4800 is a mAb measured by μ g/mL in serum, which is different from the polyclonal antibody responses to vaccines that are measured in “titers” • TNX - 4800 serum concentration enables direct PK - driven exposure targeting Three methods: • Serum ~ 5 μ g/mL – in vitro bactericidal activity • TNX - 4800 showed EC 50 ≈ 0.56 μ g/mL in vitro 1 • MEC ~ 10 times EC 50 8 • Serum <10 μ g/mL – in vitro tick feeding experiment • TNX - 4800 showed killing ≥10 μ g/mL 9 • Serum <21 μ g/mL – in vivo primate challenge model (upper benchmark) • TNX - 4800 serum levels >21 μ g/mL were 95% protective and represent an empirically observed upper correlate of protection (ceiling), not a minimum required concentration 7 Derived from Schiller et al. 7 • An adaptive phase 2 field study of TNX - 4800 is planned for 2027 • Dosing regimen: day 1 initial dose (fixed dose with ~5 mg/kg exposure) will be followed by a booster at 2 months • Primary endpoint will be decrease in Lyme disease at 6 months in TNX - 4800 arm • TNX - 4800 acts inside the tick to kill Borrelia and block the differentiation and transmission of Borrelia • Primate challenge model • Tick - mediated transmission • Stringent test (prolonged exposure to 20 infected ticks over 6 days) Preinfectious Borrelia Tick’s Midgut OspA Infectious Borrelia Tick’s Midgut and Human’s Blood Salivary Gland OspC Blood Induces Metamorphosis of Borrelia From the Preinfectious to Infectious Stage 4,5

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For the EDGAR submission types of Form 8-K: the date of the report, the date of the earliest event reported; for the EDGAR submission types of Form N-1A: the filing date; for all other submission types: the end of the reporting or transition period. The format of the date is YYYY-MM-DD.

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- Definition

The type of document being provided (such as 10-K, 10-Q, 485BPOS, etc). The document type is limited to the same value as the supporting SEC submission type, or the word 'Other'.

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No definition available.

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Address Line 1 such as Attn, Building Name, Street Name

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Address Line 2 such as Street or Suite number

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Name of the City or Town

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Code for the postal or zip code

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Name of the state or province.

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A unique 10-digit SEC-issued value to identify entities that have filed disclosures with the SEC. It is commonly abbreviated as CIK.

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Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b-2

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Indicate if registrant meets the emerging growth company criteria.

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Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b-2

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Commission file number. The field allows up to 17 characters. The prefix may contain 1-3 digits, the sequence number may contain 1-8 digits, the optional suffix may contain 1-4 characters, and the fields are separated with a hyphen.

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Two-character EDGAR code representing the state or country of incorporation.

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The exact name of the entity filing the report as specified in its charter, which is required by forms filed with the SEC.

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Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b-2

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The Tax Identification Number (TIN), also known as an Employer Identification Number (EIN), is a unique 9-digit value assigned by the IRS.

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Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b-2

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Local phone number for entity.

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Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act.

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Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 13e

-Subsection 4c

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Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act.

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Reference 1: http://www.xbrl.org/2003/role/presentationRef

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-Name Exchange Act

-Number 240

-Section 14d

-Subsection 2b

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Title of a 12(b) registered security.

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-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b

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Name of the Exchange on which a security is registered.

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-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection d1-1

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Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.

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Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 14a

-Subsection 12

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Trading symbol of an instrument as listed on an exchange.

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Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.

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-Publisher SEC

-Name Securities Act

-Number 230

-Section 425

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